A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?

• A.Write a memo to file since the change does not impact product safety and effectiveness.
• B.Prepare regulatory submissions that detail the medical device's change in materials.
• C.No action is needed in this situation.
• D.Review the content of change and supporting data for the equivalency with the current material.

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Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

• A."Product X is a guaranteed cure for arthritis."
• B."Product X is effective for the treatment of arthritis."
• C."Product X is effective in all patients with arthritis."
• D."Product X is safe for arthritis and without side effects."

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During face-to-face meetings with the regulatory authority to address submission issues, what is the BEST choice for the number of company representatives who should attend?

• A.The minimum number of attendees necessary to address the issues
• B.All senior management from the main office
• C.As many as required by international standards
• D.As many as government attendees

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According to ICH, which of the following components of study information is NOT required in a clinical study report?

• A.Randomization scheme and codes
• B.Detailed CV of all investigators
• C.List of lECs or lRBs
• D.Protocol and protocol amendments

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According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

• A.Deficiency of a device found by the user prior to patient use
• B.Adverse event caused by patient conditions
• C.Malfunction occurring before the end of service life of the medical device
• D.Malfunction protection operated correctly

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